MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*RL TITANIUM STAPLER; STAPLE, IMPLANTABLE

Catalog Number	TL60
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch # unk.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.
Event or Problem Description
It was reported via literature article entitled: three year result of laparoscopic vertical banded gastroplasty author : erik naslund, jacob freedman, jesper lagergren, dag stockeld, lars granstrom citation: obesity surgery, 9, 369-373, 1999.The study aimed to evaluate the results of the laparoscopic vertical banded gastroplasty (vbg) in 60 patients with a follow-up of 6-36 months.Between jan1995 and feb1998, 60 massive obesity patients (n=10 male and n=50 female; age of 41.9±1.4 years) lap vbg where 15 cases were converted to open vbg due to large left lobe of the live (n=13), gastric perforation (n=1) and splenic injury (n=1).In the lap vbg, the upper midline port was changed to a 33-mm port (lkt 33 ¿ ethicon) and the ecs 25 circular stapler was introduced and fired with a 32f nasogastric catheter placed in the stomach along the lesser curvature to guide the positioning of the stapler.The left working port was changed to an 18-mm port (tec 18 ¿ ethicon) and the 60-mm etc 460 linear stapler was introduced and placed alongside the 32f catheter through the circular hole up to the angle of his.Two patients in the lap vbg group were found to have staple-line disruption.The stapler used in this study consists of 4 rows, and the staple-line is not divided.Also, the staple-line is shorter (-4 cm), which may affect the rate of staple-line disruption.One added benefit of lap vbg is that reoperation with a laparoscopic technique is often possible.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7733172
• Report Number: 3005075853-2018-11695
• Device Sequence Number: 1588413
• Product Code: GDW
• UDI-Device Identifier: 20705036013188
• UDI-Public: 20705036013188
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: TL60
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention